MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	CR TIBIAL INSERT SZ3, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient, who had a right knee implanted on an unknown date, underwent a revision due to excessive wear to the implants on (b)(6) 2022.The patient was successfully revised to truliant tibial components utilizing tibial augment blocks and crc liner.Also successfully revised patella.The patient was last known to be in stable condition following the event.The devices are available for return.No other patient information/medical history reported.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: d10: concomitants: 200-01-03 - cemented cr femoral sz 3 9940194.200-02-35 - three peg patella 35mm 3709876.204-04-33 - trapezoid tibial tray sz 3f/3t 3634497.204-32-01 - fluted stem extension 11l x 12 mm 3717187.204-70-00 - tibial stem ext.Screw 3724524.H6: the revision reported was likely the result of prosthesis wear over 8 years of implantation.Contributing factors to the severity of the wear on the returned tibial insert may have been result of being packaged in a non-conforming vacuum bag for five years, rotational malalignment, and/or instability of the knee combined with high-in vivo loading.However, the contributions of each to the sequence of events cannot be determined as limited clinical information was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, h6 - health effect - clinical code, component code, type of investigation, investigation findings, investigation conclusion, h7 (remove information).If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15414090
• Report Number: 1038671-2022-01102
• Device Sequence Number: 5620529
• Product Code: JWH
• UDI-Device Identifier: 10885862040251
• UDI-Public: 10885862040251
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2018
• Device Model Number: CR TIBIAL INSERT SZ3, 11MM
• Device Catalogue Number: 200-23-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2022
• Supplement Date Received by Manufacturer: 02/28/2023; 04/20/2026
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 03/13/2023; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female